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Drug Approvals

An approved drug is a formulation that has been validated for a therapeutic use by a ruling regulatory authority. Here, we cover the latest in big drug approvals and explore how these new therapies could impact the industry.

Articles

FDA hands Biohaven refusal to file letter

The company plans to request a Type A meeting with the agency to discuss its spinocerebellar ataxia type 3 treatment

FDA decisions to watch in 2023

The agency is facing a busy year, with potential novel drug approvals ranging from gene therapies to RSV jabs

FDA approves BMS psoriasis TYK2 inhibitor

The approval hinged on results from BMS’ Phase 3 PSO-1 and POETYK PSO-2 clinical trials, which compared Sotyktu (deucravacitinib), to both a placebo and Amgen’s Otezla

Fresenius Kabi snags its first biosimilar approval

Stimufend is now the company’s first approved U.S. biosimilar, but the sixth FDA-approved biosimilar for pegfilgrastim

FDA approves Imbruvica for kids with chronic graft-versus-host disease

According to Janssen, 52-65% of children undergoing allogenic transplants develop cGVHD

News

FDA approves Axsome first rapid-acting antidepressant

UK grants Moderna first Omicron booster approval

AstraZeneca, Daiichi Sankyo grab first FDA approval for targeted HER2-low breast cancer drug

FDA approves new indication for Pfizer cancer drug

FDA grants EUA for Novavax COVID jab

FDA approves Alnylam hATTR neuropathy drug

10 tips for improved drug development

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

Dermavant snags first novel approval in topical psoriasis treatment in 25 years

The U.S. regulator has approved Dermavant Sciences' Vtama for the topical treatment of plaque psoriasis — making the cream the first and only FDA-approved steroid-free topical...

FDA rejects UCB psoriasis blockbuster hopeful

The FDA delayed its approval decision for UCB’s psoriasis drug bimekizumab Biologics License Application for the second time

Lilly snags first FDA approval for COVID JAK inhibitor

After authorizing its emergency use last year, the FDA has approved Eli Lilly’s Olumiant as a treatment for certain patients hospitalized with COVID-19

Pulling antibiotics from the fire

Can policy reform save a market in peril?

FDA approves BioXcel schizophrenia, bipolar disorder drug

The drug was developed using the company’s artificial intelligence platform

Moderna seeks EUA for fourth COVID vax dose

Moderna has asked the FDA for Emergency Use Authorization of a fourth COVID vax dose for adults 18 and older

HIV: An ending in the balance

Incorporating cures into pharma's HIV epidemic equation

FDA passes on Gilead HIV drug

The U.S. FDA said not yet to Gilead Sciences Inc.’s new HIV drug with a complete response letter, after citing quality control issues as the reason for the hold

FDA says no to Amryt rare skin disease gel

The FDA has denied approval for Amryt Pharma’s topical gel for a group of rare skin diseases and asked the company to provide additional information